IBUPROFEN (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 5 mL Cup Label

Delivers 5 mL
NDC 0121-4774-05

I BUPROFEN
O RAL S USPENSION USP

100 mg/5 mL SHAKE WELL

FOR INSTITUTIONAL USE ONLY Rx ONLY

MFG. BY: PERRIGO PHARMACEUTICALS CO.
ALLEGAN, MI 49010

PKG. BY: PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605

SEE INSERT

A47740500

PRINCIPAL DISPLAY PANEL -- 5 mL Cup Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

Delivers 10 mL NDC 0121-1548-10

I BUPROFEN
O RAL S USPENSION USP

200 mg/10 mL SHAKE WELL

FOR INSTITUTIONAL USE ONLY
Rx ONLY

PKG. BY: PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605

SEE INSERT

A4774100917

PRINCIPAL DISPLAY PANEL -- 10 mL Cup Label
(click image for full-size original)
IBUPROFEN ibuprofen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-4774(NDC:45802-952)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
ANHYDROUS CITRIC ACID
HIGH FRUCTOSE CORN SYRUP
D&C RED NO. 33
FD&C YELLOW NO. 6
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
XANTHAN GUM
Product Characteristics
Color orange Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-4774-40 4 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-4774-40) and contains a CUP, UNIT-DOSE (0121-4774-05)
1 NDC:0121-4774-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-4774-40)
2 NDC:0121-4774-10 4 TRAY in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-4774-10) and contains a CUP, UNIT-DOSE
2 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-4774-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076925 09/23/2004
IBUPROFEN ibuprofen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-1548
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
ANHYDROUS CITRIC ACID
HIGH FRUCTOSE CORN SYRUP
D&C RED NO. 33
FD&C YELLOW NO. 6
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
XANTHAN GUM
Product Characteristics
Color orange Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-1548-40 4 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-1548-40) and contains a CUP, UNIT-DOSE (0121-1548-10)
1 NDC:0121-1548-10 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-1548-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076925 09/23/2004
Labeler — Pharmaceutical Associates, Inc. (044940096)
Establishment
Name Address ID/FEI Operations
L. Perrigo Company 006013346 manufacture (0121-4774), manufacture (0121-1548)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc. 097630693 repack (0121-4774), repack (0121-1548)

Revised: 01/2018 Pharmaceutical Associates, Inc.

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